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Recruiting NCT04278469

Clinical High and Genomic Low Hormone Receptor-positive Early Breast Cancer Patients With or Without Adjuvant Chemotherapy

No phase Interventional Early Hormone Receptor-positive Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chemotherapy Drugs, Cancer.
Who it may be relevant to
Registry conditions: Early Hormone Receptor-positive Breast Cancer. Basic parameters: 19 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Randomized, Comparative Study to Evaluate Efficacy of Anticancer Chemotherapy in Predicting Prognosis and Determining Chemotherapy Method in Early Hormone Receptor-positive Breast Cancer Patients With Clinicopathological High Risk and GenesWell™ BCT Low Risk at Multi-center in Korea

Overview

A prospective, randomized, comparative study to evaluate efficacy of anticancer chemotherapy in predicting prognosis and determining chemotherapy method in early Hormone Receptor-positive breast cancer patients with clinicopathological high risk and GenesWell™ BCT low risk at multi-center in Korea

Interventions

  • Drug Chemotherapy Drugs, Cancer
    Clinical high and genomic low Hormone Receptor-positive early breast cancer patients with or without adjuvant chemotherapy

Primary outcome measures

  • 10-year distant metastasis free survival [Time frame: up to 10 years]
Secondary outcome measures (2)
  • disease free survival [Time frame: up to 10 years]
  • overall survival [Time frame: up to 10 years]

Eligibility criteria

Inclusion criteria

  • Adult women aged 19-80 at screening
  • Histologically invasive carcinoma
  • Hormone receptor positive (Estrogen, ER+ and/or Progesterone, PR+)
  • Human epidermal growth factor receptor 2 negative (HER2-)
  • Axillary lymph node assessment: pN0 or pN1
  • Tumor size≥0.5cm
  • Clinical high risk (based on modified Adjuvant! Online)
  • Patients who agree to genetic testing
  • Patients who have adequate organ function
  • Genomic low risk (based on GenesWell BCT)
  • De novo primary cancer
  • Patients how performed surgery with curative aim
  • Patients who have provided written informed consent themselves

Exclusion criteria

  • Hormone receptor negative (Estrogen, ER- and Progesterone, PR-)
  • Human epidermal growth factor receptor 2 positive (HER2+)
  • Axillary lymph node assessment: pN2 or pN3
  • Patients who are received chemotherapy prior to operation
  • Patients who are received radiotherapy prior to operation
  • Tumor size<0.5cm
  • Clinical low risk
  • FFPE tumor sample is not available
  • Patients with following conditions:
  • Patient with chronic liver disease
  • Patient with cerebrovascular disease
  • Patient with chronic mental disorder
  • Pregnant women, women of childbearing potential or lactating women
  • Patients who are deemed inappropriate as study participants by investigators
  • Patients with recurrent breast cancer or treatment history of breast cancer
  • Patients who have not undergone surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Samsung Medical Center — Seoul

Identifiers

NCT: NCT04278469 · GCX-BCT-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗